OINTMENTS

V.MANIMARANLECTURERDEPARTMENT OF PHARMACEUTICSSRM COLLEGE OF PHARMACY

UNIT VI

OINTMENTS“OINTMENTS ARE SEMISOLID

DOSAGE FORMS INTENDED FOR EXTERNAL APPLICATION TO SKIN OR MUCOUS MEMBRANE”

EITHER MEDICATED OR NON MEDICATED

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.MEDICATEDEITHER DISSOLVED OR DISPERSED IN A VEHICLE AS FINE POWDER e.g STEROIDS..UNMEDICATED

UNMEDICATED OINTMENTS ARE USED FOR PHYSICAL EFFECTS SUCH AS PROTECTANTS or LUBRICANTS

. OINTMENT BASESOINTMENT BASES ARE CLASSIFIED INTO FOUR GENERAL GROUPS.

OLEAGINOUS BASES....

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ABSORPTION BASES.WATER-REMOVABLE BASES.WATER-SOLUBLE BASES.

OLEAGINOUS BASES(HYDROCARBON BASES)

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ON APPLICATION TO SKIN THEY HAVE AN EMOLLIENT EFFECT.

PROTECT AGAINST ESCAPE OF MOISTURE.THEY ARE EFFECTIVE AS OCCLUSIVE DRESSINGS.

IMMISCIBLE WITH WATER AND DIFFICULT TO WASH OFF.

. THEY CAN REMAIN ON SKIN FOR LONGER PERIODS WITHOUT DRYING OUT.WATER AND AQUEOUS SOLUTIONS IN SMALL AMOUNTS CAN BE INCORPORATED WITH SMALL DIFFICULTY.

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. WHEN POWDERED SUBSTANCES ARE TO BE INCORRPORATED LIQUID PETROLATUM IS USED AS LEVIGATING AGENT.

. THEY INCLUDE:

. PETROLATUM

. WHITE PETROLATUM

. YELLOW OINTMENT

WHITE OINTMENT.

ABSORPTION BASESTWO TYPES

THOSE THAT PERMIT INCORPORATION OF AQUEOUS SOLUTIONS RESULTING IN FORMATION OF W/O EMULSIONS

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THOSE THAT ARE ALREADY W/O EMULSIONS AND PERMIT INCORPORATION OF ADDITIONAL QUANTITY OF AQUEOUS SOLUTION

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PROPERTIES OF ABSORPTION BASES.THESE BASES MAY BE USED AS

EMOLLIENT.THEY DO NOT PROVIDE DEGREE OF OCCLUSIONTHESE BASES ARE NOT EASY TO REMOVE FROM SKIN SINCE THE EXTERNAL PHASE OF EMULSION IS OLEAGINOUS

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DIFFICULT TO WATER WASHING.

THEY PERMIT INCORPORATION OF AQUEOUS SOLUTION RESULTING IN FORMATION OF W/O EMULSION.

THEY FORM A GREASY FILM ON SKINSURFACE

THOSE THAT ARE ALREADY W/O EMULSION,THEY PERMIT SMALL QUANTITIES OF AQUEOUS SOLUTION TO BE INCORPORATED.

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THEY INCLUDE:.LANOLIN

ANHYDROUS LANOLIN

COLD CREAM

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WATER REMOVABLE BASES(EMULSIFYING BASES)

THEY ARE OIL IN WATER EMULSIONS HAVING AN EMULSIFIER WHICH MAKES THEM READILY MISCIBLE WITH WATER.THEY MAY BE DILUTED WITH WATER OR AQUEOUS SOLUTIONS.

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.BECAUSE OF THEIR SURFACE ACTIVE PROPERTY THEY FACILITATE CONTACT b/w SKIN AND MEDICAMENT

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READILY WATER WASHABLE.THEY INCLUDE:.HYDROPHILLIC OINTMENTS.VANISHING CREAMS.

WATER SOLUBLE BASES

UNLIKE OTHER BASES THEY CONTAIN ONLY WATER SOLUBLE COMPONENTS

(GREASELESS BASES).

THEY ARE COMPLETELY WATER WASHABLE

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AQUEOUS SOLUTIONS CAN NOT BE INCORPORATED EFFICIENTLY BECAUSTHEY SOFTEN GREATLY WITH WATER ADDITION

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THEY MOSTLY ARE USED FOR INCORPORATION OF SOLID SUBSTANCES

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THESE BASES ARE USED FOR LOCAL ANAETHETICS AND ARE USED WHEN EASY WASHING FROM SKIN IS REQUIRED

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THEY INCLUDE:.PEG OINTMENT.

SELECTION OF APPROPRIATE BASEDEPENDS UPON PURPOSE FOR WHICH OINTNENT IS GOING TO BE APPLIED

.DESIRED RELEASE OF DRUG SUBSTANCE FROM OINTMENT BASE

DESIRABILITY OF TOPICAL ABSORPTION

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.DESRABILITY OF OCCLUSION OF MOISTURE FROM SKIN

.STABILITY OF DRUG IN OINTMENT BASE.DESIRABILITY OF SURFACE TO WHICH IT IS TO BE APPLIED

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EQUALLY EFFICIENT ON DRY AND OILYSKINSHOULD HAVE A SUITABLE PH.

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NO DEHYDRATING EFFECTNON IRRITANT AND NON SENSITISING

..COMPATIBLE WITH A LARGE NUMBER OF DRUGS

.MISCIBLE WITH SKIN SECRETIONS ANDEXCRETIONS e.g SEBUM ,SWEAT etc

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TWO GENERAL METHODS DEPENDING PRIMARILYON NATURE OF INGREDIENTS AND PHYSICAL PROPERTIES OF CONSTITUENS OF BASE

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INCORPORATION

FUSION

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INCORPORATION OF SOLIDS

INCORPORATION OF LIQUIDS

INCORPORRATION

INCORPORATIONTHE COMPONENTS ARE MIXED UNTIL A UNIFORM PREPARATION IS ATTAINED

ON SMALL SCALE AS IN EXTEMPORANEOUS COMPOUNDING THE COMPONENTS ARE MIXED USNG PESTLE AND MORTAR OR SPATULA MAY BE USED TO RUB INGREDIENTS ON AN OINTMENT SLAB

MEDICAMENT IS MIXED WITH SMALL AMOUNT OF BASE AND REMAINDER IS MIXED GRADUALLY AND TRITURATED CONTINEOUSLY

IF MATERIAL TO BE INCORPORATED IS SOLID THEN FIRSTSOLID IS TRITURATED TO FINE POWDER AND THEN SHOULD BE INCORPORATED

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(INCORPORATION OF SOLID)

IT IS OFTEN DESIRABLE TO REDUCE PARTICLE SIZE OF CRYSTALLINE MATERIAL SO THAT FINAL PRODUCT WILLNOT BE GRITTYTHIS IS DONE BY LEVIGATING OR MIXING SUBSTANCE INA VEHICLE IN WHICH IT IS INSOLUBLE SO THAT A SMOOTH DISPERSION IS FORMED

LEVIGATING AGENT SHOULD BE IN EQUAL VOLUME TO SOLID MATERIAL

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IF MATERIAL TO BE INCORPORATED IS SOLUBLE IN ONE OF INGREDIENTS OF BASE ,FIRST DISSOLVE IN THAT INGREDIENT AND THEN INCORPORATE

.TWIN-ROLLER MILLS ARE AVAILABLE FOR PREPARATION OF SMALL QUANTITIES OF OINTMENTS BY HAND

.IF INGREDIENTS OF OINTMENTS ARE REACTIVE WITH STAINLESS STEAL SPATULA(AS DOES IODINE FOR EXAMPLE)HARD RUBBER SPATULA MAY BE USED

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INCORPORATION(INCORPORATION OF LIQUID)

LIQUIDS ARE ADDED ONLY AFTER DUE CONSIDERATION OF AN OINTMENT BASE CAPACITY TO ACCEPT VOLUME REQUIRED

ONLY SMALL AMOUNT OF AQUEOUS SOLUTION IS INCORPORATED INTO OLEAGINOUS OINTMENT

HYDROPHILLIC OINTMENTS READILY ACCEPT LARGE VOLUMESWHEN IT IS NECESSARY TO ADD AQUEOUS PREPARATION TO HYDROPHOBIC BASE,SOLUTION FIRST MAY BE INCORPORATED INTO MINIMUM AMOUNT OF HYDROPHILLIC BASE AND THEN ADDED TO HYDROPHOBIC BASE

ALL LIQUIDS HAVE THEIR LIMITS TO RETAIN LIQUIDS BEYOND WHICH THEY BECOME TOO SOFT OR SEMISOLID

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FUSIONMEDICATED OINTMENTS AND OINTMENT BASES CONTAINING COMPONENTS SUCH AS BEESWAX,PARAFFIN,STEARYL ALCOHOL AND HIGH M.W PEGs WHICH DO NOT LEND THEMSELVES WELL TO MIXURE BY INCORPORATION ARE PREPARED BY FUSION

OINTMENTS CONTAINING INGREDIENTS WHICH ARE QUITE SOLID AT ROOM TEMPERATURE ARE PREPARED BYMELTING INGREDIENTS IN A PORCELAIN DISH OVER WATER BATH

THE USUAL METHOD IS TO MELT SUBSTANCE WITH HIGHEST MELTING POINT FIRST,AND THEN ADD INGREDIENTS IN ORDER OF THEIR MELTING POINTS

SRIRRING SHOULD BE CONTINEOUS UNTILL OINTMENT IS HOMOGENEOUS AND REACHES TO CONGEALING POINT

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AN INSOLUBLE SUBSTANCE IS INCORPORATED AFTER LEVIGATING WITH OIL

ON LARGE SCALE FUSION IS CARRIED OUT IN STEAM JACKETED KETTLES

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TOPICAL APPLICATIONS ARE NOT REQUIRED TOBE STERILE,HOWEVER CONSIDERATION MUST BE GIVEN TO INFECTIOUS RESPONSE CAUSED BY CERTAIN MICROORGANISMS

DERMATOLOGIC PRODUCTS SHOULD BE FREE OF:

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STAPHYLOCOCCUS AUREUS

PSEUDOMONAS AERUGINOSA

BASES HAVING HIGH WATER CONTENT SUPPORT MICROBIAL GROWTH

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AMONG THE ANTIMICROBIAL PRESERVATIVES USED TO INHIBIT MICROBIAL GROWTH IN TOPICAL PREPARATIONS ARE:

METHYLPARABEN

PROPYLPARABEN

PHENOLS

BENZOIC ACID

SORBIC ACID

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FILLING IS DONE BY TWO WAYS:

HAND FILLING

MECHANICAL FILLING

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HAND FILLING:

WEIGHTED AMOUNT OF OINTMENT IS PLACED IN A JAR WITH THE HELP OF FLEXIBLE SPATULA

OINTMENT IS FORCED DOWN TO BOTTOM AND ALONG WALLS OF JAR TO AVOID AIR ENTRAPMENT

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MECHANICAL FILLING:

IN THIS METHOD OINTMENTS CAN BE FILLED IN TIN JARS AND POLYETHYLENE TUBES

FILLING IS DONE BY PRESSURE FILLER WHICH CONSIST OF NOZEL AND PISTON FROM WHICH OINTMENT OOZES OUT ON APPLYINGPRESSURE ON PISTONTUBES ARE FILLED FROM BACK SIDE AND THEN ARE SEALED

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VACCUM FILLERS ARE ALSO AVAILABLE IN WHICH NOZEL IS ATTACHED TO VACCUM PUMP

AN OINTMENT FILLER

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OINTMENTS SHOULD BE PACKAGED SO THAT THERE ARE NO AIR SPACES IN JAR

MUST BE STORED IN WELL CLOSED CONTAINER TO AVOID CONTAMINATION

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STORE AT COOL PLACE TO AVOID SOFTENING AND LIQUIFICATION OF BASE

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IT SHOULD BE LABELLED AS:

“FOR EXTERNAL USE ONLY”

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“VISCOUS LIQUID OR SEMISOLID EMULSIONS FOR APPLICATION ON SKIN AND MUCOUS MEMBRANE”

CREAMS MAY BE:

FOR SPECIFIC ACTION

EMOLLIENT

e.g FOR APPLICATION ON BURNS

MEDICATED

NON-MEDICATED

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TWO TYPES:WATER IN OIL OR OILY CREAMS:

CONTAIN W/O EMULSIFIER e.g WOOL FATS AND WOOL ALCOHOLEXAMPLES:

COLD CREAMZINC CREAM

OIL IN WATER OR AQUEOUS CREAMS:

CONTAIN O/W EMULSIFIER e.g EMULSIFYING WAX ALKALI SALT OF A FATTY ACIDEXAMPLES:

VANISHING CREAM HYDROCORTISONE CREAM

OIL IN WATER EMULSIONS CONTAIN LARGE PERCENTAGE OF WATER,STEARIC ACID AND OTHER OLEAGINOUS COMPONENTS

AFTER APPLICATION WATER EVAPORATES AND LEAVES BEHIND A THIN RESIDUE FILM OF STEARIC ACID AND OLEAGINOUS COMPONENT

SO IT IS PROTECTANT IN NATURE

CREAMS ARE PREPARED BY DISPERSING OR DISSOLVING MEDICINAL AGENTS IN EMULSIONIN EXTEMPORANEOUS PREPARATION PESTLE AND MORTAR IS USED (A MECHANICAL BLENDER)TO PREPARE EMULSION

EMULSIFYING AGENT IS MIXED WITH OILAND THEN WATER IS ADDED

AFTER FORMATION OF EMULSION MEDICINAL AGENTS OF CREAM ARE DISPERSED

ADVANTAGES OVER OINTMENTS

CREAMS ARE EASIER TO SPREAD THAN OINTMENTS

AQUEOUS CREAMS ARE EASY TO WASH THAN ALL OINTMENTS

SAME PACKAGING AS OINTMENTS:

CREAMS SHOULD BE PACKAGED SO THAT THERE ARE NO AIR SPACES IN JAR

MUST BE STORED IN WELL CLOSED CONTAINER TO AVOID CONTAMINATION

AMONG THE ANTIMICROBIAL PRESERVATIVES USED TO INHIBIT MICROBIAL GROWTH IN TOPICAL PREPARATIONS ARE:

METHYLPARABEN

PROPYLPARABEN

PHENOLS

BENZOIC ACID

SORBIC ACID

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PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS

ANSEL’S

NASIR HAYYAT SIPRA

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